3D Printing to Improve Nasal Irrigation Outcome

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT06118554
Status
Recruiting
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Conditions

  • Chronic Rhinosinusitis With Nasal Polyps
  • Chronic Rhinosinusitis Without Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Irrigation head position — OTHER
    Patients irrigated their sinuses with once daily 2 mg mometasone using 240 mL NeilMed sinus rinse bottles for 8 weeks. The only factor that varied between groups was the head position patients irrigated in.

Study Details

Three-dimensional (3D) printing has been an emerging technology with uses in a wide array of fields. This research aims to use 3D printing as a tool to provide personalized education to maximize treatment efficacy based on the patient's individual anatomy. With increased irrigation to the sinuses, we hypothesize there will be improved patient satisfaction and higher quality of life. The outcomes of this research could lead to a new option for patients who live with chronic rhinosinusitis are not candidates for surgery or are interested in less invasive options. The 3D printed nasal replica is not something that would be implanted, rather it is a hand-held device used specifically for participants to better understand their nasal anatomy.

Key Dates

Start date
Nov 1, 2021
Status verified
May 2026
Primary completion
Jun 26, 2027
Completion
Dec 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    The control group (CG) irrigated in the standard FDA consumer-recommended position, defined as leaning forward with a natural ear-to-shoulder head tilt.
  • Experimental: Backfill group
    Backfill group (BG) subjects irrigated with a head tilt of 90 degrees ear-to-shoulder and used the nostril closest to the ground.
  • Experimental: Model group
    Finally, the model group (MG) irrigated in an optimal position based on their 3D nasal replica. This patient-specific position was communicated to each MG patient with clear instructions during an in-person training session.

Primary Outcome Measure

Nasal Obstruction Symptom Evaluation (NOSE) score [ Time Frame: completed at baseline and after 8 weeks of treatment. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Eye and Ear InstitueColumbusOhio43212
Kai Zhao, PhD
[email protected]
2673032322
Kai Zhao, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
The Ohio State University Eye and Ear Institue· Columbus, OH

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